Effectiveness of vortioxetine in patients with major depressive disorder and comorbid Alzheimer’s disease in routine clinical practice: An analysis of a post-marketing surveillance study in South Korea

Abstract

BackgroundVortioxetine has demonstrated procognitive effects in patients with major depressive disorder (MDD). We assessed the effectiveness and safety of vortioxetine in a cohort of patients with MDD and comorbid Alzheimer’s disease participating in a large post-marketing surveillance study in South Korea.MethodsSubgroup analysis of a 6-month, prospective, multicenter, non-interventional cohort study in outpatients with MDD with a pre-baseline diagnosis of Alzheimer’s disease receiving vortioxetine in routine care settings (n = 207). Patients were assessed at baseline and after 8 weeks; a subset of patients was also assessed after 24 weeks. Depression severity was assessed using the Montgomery–Åsberg Depression Rating Scale (MADRS) and Clinical Global Impression (CGI) scale, cognitive symptoms using the Perceived Deficits Questionnaire–Depression, Korean version (PDQ-K), and cognitive performance using the Digit Symbol Substitution Test (DSST).ResultsMost patients were receiving a mean daily vortioxetine dose of 5 mg/day (174/190 patients; 91.6%). After 24 weeks of vortioxetine treatment, 71.4% of patients (40/56) had experienced overall clinical improvement (i.e., CGI–Improvement score ≤3) and 51.9% (28/54) had achieved remission from depressive symptoms (i.e., MADRS total score ≤10 points). Respective mean changes in MADRS, PDQ-K, and DSST total scores from baseline to week 24 were −11.5 (p < 0.0001), −5.1 (p = 0.03), and +3.8 points (p = 0.0524). Adverse events were reported by 27 patients (13.0%) and were mostly mild (89.2%).ConclusionPatients with MDD and comorbid Alzheimer’s disease receiving vortioxetine in routine care settings in South Korea demonstrated clinically meaningful improvements in depressive symptoms, cognitive symptoms, and objective cognitive performance over the 6-month treatment period. Treatment with vortioxetine was well tolerated in this patient cohort, with reported adverse events consistent with the established tolerability profile of vortioxetine.

Treating Depression in Dementia Patients: A Risk or Remedy—A Narrative Review

“…A newer SSRI, vortioxetine, has a broad range of effects on depressive symptoms, including cognitive symptoms [ 35 , 36 ]. An observational study by Cumbo E. et al [ 37 ] reported improvement in depressive symptoms in those with mild AD [ 37 , 38 ]. However, an RCT reported no superiority of vortioxetine over a placebo in improving depression [ 39 ].…”

The Role of Vortioxetine in the Treatment of Depressive Symptoms in General Hospital Psychiatry: A Case-Series and PRISMA-Compliant Systematic Review of the Literature

“…These articles report encouraging results in the treatment of negative, cognitive and affective symptoms of schizophrenia [108][109][110], along with preliminary effectiveness in bipolar depression [111], burning mouth syndrome [112], postmenopausal depression [113], and panic disorder [114]. A further group of studies (n = 5) demonstrated that vortioxetine treatment is associated with affective and cognitive symptoms amelioration in patients with neurological conditions, including neurocognitive decline [115][116][117], Parkinson's disease [118], and post-stroke depression [119]. Interestingly, three studies report data suggesting that vortioxetine could be an effective strategy to reduce SSRI-induced emotional blunting [120][121][122].…”

Depression in the elderly – the position of vortioxetine

“…Działania niepożądane zgłosiło 27 pacjentów (13,0%) i były one w większości łagodne (89,2%). Po 24 tygodniach leczenia wortioksetyną u 71,4% pacjentów nastąpiła ogólna poprawa kliniczna, 51,9% osiągnęło remisję objawów depresyjnych [34]. Zestawienie wyników dotyczących skuteczności wortioksetyny przedstawiono na rycinach 1 i 2.…”

“…Wyniki globalnej poprawy klinicznej (CGII) u pacjentów z ciężkimi zaburzeniami depresyjnymi i współistniejącą chorobą Alzheimera po 8 i 24 tygodniach leczenia wortioksetyną (zestawienie analizy skuteczności). Bardzo duża poprawa: CGII = 1, znaczna poprawa: CGII = 2, minimalna poprawa: CGII = 3, bez zmian: CGII = 4, pogorszenie: CGII ≥ 5 [34] bardzo duża poprawa znaczna poprawa minimalna poprawa brak poprawy pogorszenie A B [36]. Pacjenci odnotowali również znaczną poprawę w zakresie codziennego i ogólnego funkcjonowania, zadowolenia z życia oraz jakości życia (HRQoL, BASQID) [37].…”

“…Średni (SD) całkowity wynik MADRS (A) i PDQK (B) na początku badania oraz po 8 i 24 tygodniach leczenia wortioksetyną (zestawienie analizy skuteczności)[34] …”